On November 17, 2021, Arcus Biosciences, Inc. ("Arcus") reported that entered into an amendment to its Option, License and Collaboration Agreement with Gilead Sciences, Inc. ("Gilead") dated May 27, 2020 (the "Collaboration Agreement") (Filing, 8-K, Arcus Biosciences, NOV 17, 2021, View Source [SID1234595756]). Pursuant to the amendment, Gilead exercised its options to three Arcus programs—its anti-TIGIT program (including domvanalimab and AB308), adenosine receptor antagonist program (including etrumadenant) and CD73 program (including quemliclustat). This transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act. Upon closing, Gilead will pay Arcus an aggregate of $725 million in option fees for its option exercise with respect to these three programs. Thereafter, in accordance with the terms of the Collaboration Agreement, as amended for these three programs, the companies will co-develop, equally share global development costs and equally share all profits and losses for the United States, subject to certain expense caps on Arcus’s spending and true-up adjustments. Gilead will obtain rights to exclusively commercialize these optioned programs outside of the U.S., subject to the rights of Arcus’s existing collaboration partners to any territories, and Gilead will pay to Arcus tiered royalties as a percentage of revenues ranging from the mid-teens to the low twenties.

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In addition, the parties agreed to collaborate on discovery and early development of drug candidates against two novel research targets ("research programs") for which Arcus will lead performance of discovery and early development activities. With respect to these two research programs, Gilead has the right to exercise its option, on a program-by-program basis, upon Arcus’s completion of certain IND-enabling activities for an option payment of $60 million. If the option is exercised by Gilead at this stage, the collaboration terms for optioned programs will be applicable to each research program except, with respect to commercialization outside of the U.S., Gilead would pay to Arcus tiered royalties as a percentage of revenues ranging from high single digits to low double digits. If Gilead declines to exercise its option at this stage, Gilead maintains an option, on a program-by-program basis, which must be exercised prior to the expiration of a prescribed period following the achievement of a development milestone in such program and Arcus’s delivery to Gilead of the requisite data package. If the option is exercised by Gilead at this later stage, the collaboration terms for optioned programs will be applicable to the joint development program including that, with respect to commercialization outside of the U.S., Gilead would pay to Arcus tiered royalties as a percentage of revenues ranging from the high-teens to the low twenties.

In connection with Gilead’s exercise of its options to three Arcus programs, the parties agreed to amend the $100 million option continuation payment due on the second anniversary of the Collaboration Agreement (the "2022 Continuation Payment"). Upon closing for all three programs, Gilead will no longer be obligated to make the 2022 Continuation Payment. In the event closing only occurs for one program, the 2022 Continuation Payment will be reduced to $67 million. In the event closing only occurs for two programs, the 2022 Continuation Payment will be reduced to $34 million.

The foregoing is only a brief description of the material terms of the amendment to the Collaboration Agreement and does not purport to be a complete description of its terms and is qualified in its entirety by reference to the amendment, which will be filed as an exhibit to Arcus’s Annual Report on Form 10-K for the year ending December 31, 2021.

On November 17, 2021 Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, reported it has closed $16M in Series A financing (Press release, Alpheus Medical, NOV 17, 2021, View Source [SID1234595755]). Co-led by OrbiMed Advisors and Action Potential Venture Capital, the round included participation from the Medtech Convergence Fund, a SV Health Investors venture fund, the Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society, and BrightEdge, the American Cancer Society’s impact venture capital arm. The company’s investigational non-invasive sonodynamic therapy has the potential to offer whole hemisphere treatment that is designed to selectively target and kill cancer cells through an outpatient procedure that may be repeated, as needed, to treat the disease. The funds will support a FIH trial of the therapy for recurrent glioblastoma multiforme (rGBM), a fatal brain cancer with very limited treatment options.

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The multi-site first-in-human trial will evaluate the safety, feasibility, and molecular and clinical effects of the proprietary sonodynamic therapy treatment in patients with recurrent high-grade gliomas. Enrollment is expected to begin in the coming months.

"Alpheus’ unique drug-device combination is poised to overcome the challenges of rGDM tumors"

"Glioblastomas are located within the blood-brain barrier and are very difficult to treat due to their heterogenous and invasive nature. Treatment of these devastating tumors is currently limited by procedures that are highly invasive, may not be repeated, often result in complications, and in many situations lead to undesirable quality of life trade-offs for the patient," commented Klaus Veitinger, MD, Venture Partner at OrbiMed Advisors and Executive Chairman of Alpheus Medical’s board of directors. "Our team has followed the brain cancer market closely. Alpheus’ unique drug-device combination is poised to overcome the challenges this tumor poses and deliver the hope of better outcomes for these critically ill patients."

Alpheus Medical’s drug-device combination uses a sonodynamic approach, where a drug, or sonosensitizer, selectively accumulates in cancer cells and is activated under low intensity ultrasound to kill the tumor cells. After the drug is administered, Alpheus’ proprietary ultrasound delivery device provides SDT treatment to activate cell death in only the cancer cells that have absorbed the drug. Alpheus’ therapy aims to address the heterogenous and diffuse nature of the disease with its large field treatment of cells both at the primary tumor site and those throughout the diseased hemisphere. The innovative therapy also eliminates the requirement for concomitant imaging, such as magnetic resonance imaging (MRI). It can be performed as a convenient outpatient procedure and may be repeated to maximize treatment effect.

"The ability to selectively target cancer cells with Alpheus’ treatment is very exciting and has the potential to deliver a much-needed option for this challenging disease, where drug therapies alone have struggled," stated Imran Eba, Partner with Action Potential Venture Capital and newly appointed board member of Alpheus Medical. "We are pleased to co-lead this round and look forward to supporting the team as it moves the platform into clinical trials."

On November 17, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new drugs for the treatment of cancer and fibrosis, reported that it has received new data from its recent Phase 1 clinical trial that demonstrates the ability of AMP945 to inhibit the intended target, Focal Adhesion Kinase (FAK), in human volunteers when given as an orally administered capsule (Press release, Amplia Therapeutics, NOV 17, 2021, View Source;[email protected] [SID1234595754]). This supplementary data further strengthens the Company’s confidence in the planned Phase 2 clinical program as it shows that safe and well-tolerated oral doses of AMP945 can achieve sufficient drug levels in humans to inhibit FAK.

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The primary focus of Amplia’s recent Phase 1 clinical trial was to establish the safety, tolerability and pharmacokinetics of AMP945. As part of the trial, skin biopsies were collected from participating healthy volunteers to evaluate the ability of AMP945 to inhibit FAK in human tissues. Analysis of these samples required Amplia to develop a sensitive assay that allowed the measurement of the active form of FAK (phospho-FAK or pFAK) in skin samples before and after AMP945 was administered. The data from these studies have now been analysed and demonstrate that oral administration of AMP945 results in a decrease in active pFAK and the extent of the inhibition of FAK activity correlates with drug levels of AMP945.

In addition to demonstrating the dose-dependent reduction in pFAK in healthy volunteers, these results verify the utility of the assay used to measure pFAK in human tissue samples, confirming the availability of a test method which can be used to guide dose selection in the Company’s planned Phase 2 clinical trials of AMP945.

"We are very encouraged by the way all the data is lining up as we prepare to start our first Phase 2 clinical trial of AMP945," said Dr Mark Devlin, Chief Scientific Officer at Amplia. "Being able to observe inhibition of FAK in human volunteersis an important piece of the jigsaw. We have observed inhibition of FAK by AMP945 in animal models and this has been associated with anti-tumour and anti-fibrotic activity. Getting such clear and compelling FAK inhibition data in our Phase 1 trial is very pleasing and provides additional comfort as we start trialling AMP945 in patients. Furthermore, we now have an assay for monitoring the effects of AMP945 that can be used to guide dosing in our upcoming Phase 2 trials in pancreatic cancers and other fibrotic diseases."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On November 17, 2021 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 86.7 million in the third quarter of 2021 (Q3 2020: NOK 49.6), and EBITDA of NOK -0.2 million (-5.4), following the continued successful launch in markets previously operated by Ipsen Pharma SAS (Press release, PhotoCure, NOV 17, 2021, View Source [SID1234595753]). The Company plans to increase its investment in commercial activities to further penetrate the large potential market opportunity for its bladder cancer treatment.

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"Photocure continued to grow its business during the third quarter of 2021, despite the challenges that arose from the surge of Covid-19 Delta which impacted medical procedures around the world. We delivered Hexvix/Cysview revenue of NOK 86.7 million, up 75% compared to the third quarter of 2020. These results were primarily driven by our reacquisition of the Hexvix business in continental Europe and our focus on territories where healthcare access improved in the third quarter. Importantly, demand for blue light cystoscopy (BLC) equipment remains strong with 14 towers placed in the U.S. in Q3. We remain conservative on the number of towers that we expect to place over the next couple of quarters, given Karl Storz’s planned transition to a new high-definition system in 2022. We believe that launch of the upgraded BLC system is an exciting opportunity with the potential to significantly increase the installed base of BLC towers in the U.S. next year and beyond," said Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 87.4 million in the third quarter of 2021 (NOK 49.9 million), and EBITDA* of NOK -0.2 million (NOK -5.4 million). Hexvix/Cysview revenues were NOK 86.7 million (NOK 49.6 million) following the successful transition of the Ipsen territories and unit sales growth of 6% in the U.S. EBIT ended at NOK -6.3 million (-16.4) and the cash balance at the end of third quarter 2021 was NOK 330.1 million, compared to NOK 321.8 million reported in the third quarter of 2020.

The installed base of blue light cystoscopes in the U.S. was 302 at the end of the third quarter, an increase of 49 units or 19% since the same period in 2020. BLC with Cysview in the surveillance setting is a priority for Photocure in the U.S. market. By the end of the third quarter, a total base of 45 flexible cystoscopes had been installed giving more patients access to the procedure with less constraints.

"We continue to maintain a strong financial position with NOK 330 million in cash and minimal debt. We reported break-even EBITDA in the third quarter, as we continue to manage through what appears to be the tail end of the pandemic and have begun to invest more aggressively in initiatives to regain growth in our direct markets. We also reacquired the commercial rights to Cysview in Canada and are preparing to begin growing that business in January," Schneider added.

After regaining sales and marketing rights to the European markets that were previously out-licensed, the Company has established a strong commercial presence in the largest markets of the world and believes that it is well-positioned to accelerate revenues in a post Covid-19 environment. Assuming that the effects of Covid-19 and its variants can be appropriately managed, Photocure plans to increase spending back to normalized business levels in the fourth quarter of 2021, increasing investment primarily in commercial activities to grow Hexvix/Cysview unit sales.

"We are optimistic that the challenging conditions of the pandemic that have persisted for nearly two years will improve going forward. Our teams are energized to deliver patient value and revenue growth in 2022, with the expectation of new enhanced BLC equipment and focus from Karl Storz, expansion of our business into Canada, the ability of our strengthened European commercial team to have broader access to our new customers and territories, the potential to execute on enriching our portfolio through partnerships or M&A opportunities, and anticipated progress on the ongoing Phase 3 trial for Cevira. With the impact of Covid-19 expected to abate in H1 2022, Photocure remains in a strong position to get back to the growth rates that we were delivering pre-pandemic, and to capitalize on other opportunities that can enhance our growth and path toward sustainable profitability," Schneider concluded.

Please find the full financial report and presentation enclosed.

*EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the third quarter 2021 financial report on page 25.

Photocure will present its third quarter 2021 report on Wednesday 17 November 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20211117_5/

On November 17, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported its financial results for the first nine months and the third quarter of 2021, ended September 30, 2021 (Press release, Evogene, NOV 17, 2021, View Source [SID1234595752]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "I am very pleased with the overall progress and achievement of milestones we see across the board in our subsidiaries and in Evogene itself. Our subsidiaries are progressing according to plan, and we expect to hit additional milestones in the coming months. With this rapid progress, we see significant inherent value developing within each of our subsidiaries.

"As stated previously, we believe that each subsidiary, valued independently, would result in a far greater combined market value for Evogene. In this regard, we wish to unlock the value of our subsidiaries and, as disclosed, are currently examining the possibility of turning one or more of our subsidiaries into public companies. This would allow investors access to the specific subsidiary of interest and the opportunity for the markets to assign it an independent value. We are currently undertaking the required preparations in our subsidiaries to support this process and are reviewing our options regarding investment banks to achieve this target.

"Of course, the decision, if when and how to spin out a subsidiary will depend on many considerations, including market conditions, the subsidiaries financial needs, pipeline maturity, valuation, applicable regulations and other relevant aspects." Mr. Haviv concluded.

Recent Achievements:

Biomica

Immuno-Oncology program – Biomica recently signed an agreement with Rambam Health Care Campus for a clinical trial for its microbiome-based Immuno-Oncology Drug. Biomica expects to initiate its first-in-human, proof-of-concept clinical trials with Rambam later this year and is currently waiting for the approval of the Israeli Ministry of Health in order to begin.

Canonic

MetaYield program – During October 2021, Canonic initiated commercial sales of G200 and G150, part of the G-nnovation series, following positive feedback from a pre-launch campaign, in which these products were marketed in Israel to a limited number of licensed patients.

Canonic’s G200 and G150 are cannabis inflorescence products marketed under the T20/C4 and T15/C3 categories, respectively[1]. This commercial launch, which was originally scheduled for 2022, was moved forward following the aforementioned positive feedback in Israel.

AgPlenus

Appointment of a new CEO – Dr. Brian Ember has been appointed as Chief Executive Officer of AgPlenus. Dr. Ember brings extensive experience in the ag-chemicals industry, holding various senior leadership roles, including Head of Global Portfolio Management and Head of Marketing and Business Development, Americas for Biotalys, an agricultural technology company focused on reinventing food protection with protein-based biocontrol solutions; Senior Director, Business Development for AgriMetis, an innovative crop protection company; and various management roles at BASF and Syngenta.

Lavie Bio

result inoculant (previously LAV.211) – Lavie Bio announced initial commercial launch of its first microbiome-based product for yield improvement – result. This inoculant is being introduced for spring wheat following positive four-year field trials. The first phase of marketing, and initial market penetration, in the upcoming 2022 spring wheat season will be limited to target regions in North Dakota, which is estimated as an overall 6-million-acre spring-wheat market[2]. This initial phase of marketing will be accomplished under a distribution agreement with United Agronomy, as recently announced[3]. Initial sales are expected to be recorded in 2022.

Change in management – Mr. Ido Dor, Lavie Bio’s Chief Executive Officer, has announced that he is stepping down from his position. Evogene thanks Mr. Dor, who has been an integral part of the Evogene group over the past 10 years and significantly contributed to the activities and success over the years. Mr. Dor will continue to serve as a consultant of Lavie Bio. Lavie Bio is currently seeking a replacement for this position and during that period Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, will serve as an active chairman of Lavie Bio.

Evogene

CRISPR-IL consortium – The Israeli Innovation Authority (IIA) informed Evogene of its decision to fund a second 18-month period of the CRISPR-IL consortium established last year. The consortium’s mission is to develop and validate an end-to-end artificial intelligence (AI) system – "Go-Genome" – for genome-editing in multi-species for applications in pharma, agriculture, and aquaculture.

Beyond activities within the consortium’s scope, companies participating in the consortium may use "Go-Genome" for their own product development activities. In this respect, Evogene is currently conducting various proof-of-concept experiments in plant tissue, examining the feasibility of increasing the production of ingredients such as natural colors and anti-aging agents for food or cosmetic purposes.

Appointment of a new board member – Mr. Dan Falk has been appointed to Evogene’s Board of Directors, commencing November 17, 2021. Mr. Falk has extensive experience of more than 20 years in serving as a financial expert on public and private company boards, most recently on the boards of Nice Ltd., Ormat Technologies Inc. and Innoviz Technologies Ltd.. Additionally, in the past Mr. Falk held various executive positions in Orbotech Ltd. and Sapiens International Corporation.

Consolidated Financial Results Summary

Cash position: Evogene maintains a strong financial position for its activities with $61.6 million in consolidated cash, cash related accounts, bank deposits and marketable securities as of September 30, 2021, of which $9.3 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio.

During the first nine months of 2021, the consolidated net cash usage was approximately $17.3 million, or $13.6 million, if excluding Lavie Bio. This is in comparison to the first nine months of 2020, during which the consolidated cash usage was $13.4 million, or $9.3 million, if excluding Lavie Bio. These sums in 2021 exclude $29.6 million net raised through Evogene’s at-the-market, or ATM, offerings (including $2.6 million raised under its current ATM, announced in March 2021) and excludes an additional $1.0 million in proceeds from grants received and exercises of options.

During the third quarter, the consolidated cash usage, was $6.0 million, or $4.6 million, excluding Lavie Bio. This is in comparison to the third quarter of 2020, during which the consolidated cash usage was $4.6 million, or $3.0 million, if excluding Lavie Bio.

The cash burn rate during the first nine months of 2021 and in the third quarter, was higher than during the same period in 2020, for the following reasons:

During the second and third quarter of 2020, the burn rate was relatively low due to certain measures the company initiated to mitigate the impact of the COVID-19 pandemic on the Company.
During the first nine months of 2021 Evogene’s subsidiaries significantly expanded product development activities, including:
– Biomica’s ongoing preparations for the initiation of its first-in-human proof-of-concept study in the immuno-oncology program, later this year.
– Lavie Bio’s activities supporting the commercial launch of its inoculant product branded as result in 2022.
– Canonic’s pre-launch campaign, initiated in September 2021, prior to product commercialization, which took place in Israel during the fourth quarter of 2021.
Management continues to estimate that the cash usage for the full year of 2021 will be within the anticipated range of $20-$22 million. These guidelines exclude the cash usage of Evogene’s subsidiary Lavie Bio.

Research and Development ("R&D") expenses: R&D expenses for the third quarter of 2021, which are reported net of grants received, were $5.8 million, in comparison to $4.0 million in the third quarter of 2020. The increase in R&D expenses was mainly attributed to the product development activities of the Company and its subsidiaries, as mentioned above.

Business Development ("BD") expenses: BD expenses were $0.8 million for the third quarter of 2021, in comparison to $0.6 million in the third quarter of 2020. The increase was attributed mainly to Canonic’s and Lavie Bio’s preparations for commercialization.

General and Administrative ("G&A") expenses: G&A expenses for the third quarter of 2021 were $2.0 million, in comparison to $1.2 million in the third quarter of 2020. The increase was mainly attributed to the increase of the costs of directors’ and officers’ insurance policies and a relative increase in salary expenses following a temporary reduction in such expenses in the corresponding quarter in 2020, due to steps taken to mitigate the financial impact of the COVID-19 pandemic on the Company

Operating loss: Operating loss for the third quarter of 2021 was $8.6 million in comparison to $5.6 million in the third quarter of 2020.

Net loss: The net loss for the third quarter of 2021 was $8.3 million in comparison to a net loss of $5.4 million during third quarter of 2020. The increase in loss is attributed to the increase in product development activities, an increase in commercialization and marketing expenses and an increase in directors’ and officers’ insurance cost.

Replay Information: A replay of the conference call will be available approximately two hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through November 19, 2021, and an archive of the webcast will be available on the Company’s website.